US2015250800A1PendingUtilityA1

Acute treatment of headache with phenothiazine antipsychotics

Assignee: ALEXZA PHARMACEUTICALS INCPriority: May 20, 2002Filed: May 26, 2015Published: Sep 10, 2015
Est. expiryMay 20, 2022(expired)· nominal 20-yr term from priority
A61P 29/00A61K 31/553A61K 9/007A61K 31/382A61K 9/0073A61M 15/0033A61K 31/5377A61M 15/00A61K 31/4515A61K 31/445A61K 31/4439A61K 31/496A61M 2205/075A61K 31/55A61K 31/554A61M 2202/064A61K 31/551A61M 15/0028A61K 31/519A61K 31/454A61K 31/5415
44
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Claims

Abstract

Methods of treating headache with antipsychotics are provided. A kit for treating headache is also provided, comprising an antipsychotic and a device for rapid delivery of the antipsychotic.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of treating a headache comprising administering by inhalation a composition comprising an antipsychotic to a patient in need of headache relief. 
     
     
         2 . The method of  claim 1 , wherein the peak plasma concentration of the antipsychotic in the patient is obtained within 15 minutes of initiation of inhalation. 
     
     
         3 . The method of  claim 1 , wherein a therapeutic systemic concentration of the antipsychotic in the patient is obtained within 15 minutes of initiation of inhalation. 
     
     
         4 . The method of  claim 1 , wherein the concentration of antipsychotic in the plasma of the patient is at least 30 percent of the peak plasma concentration within 2 minutes of initiation of inhalation. 
     
     
         5 . The method of  claim 1 , wherein headache relief is statistically significant compared to baseline at a time point 15 minutes or less following initiation of inhalation. 
     
     
         6 . The method of  claim 1 , wherein headache relief is statistically significant compared to baseline at a time point 2 hours or less following initiation of inhalation and at a time point 12 hours or more following initiation of inhalation. 
     
     
         7 . The method of  claim 1 , wherein headache severity is decreased at a time point 5 minutes or less following initiation of inhalation. 
     
     
         8 . The method of  claim 1 , wherein headache severity is decreased at a time point 15 minutes or less following initiation of inhalation. 
     
     
         9 . The method of  claim 1 , wherein headache severity is decreased at a time point 30 minutes or less following initiation of inhalation and at a time point 4 hours or more following initiation of inhalation. 
     
     
         10 . The method of  claim 1 , wherein headache severity is decreased at a time point 2 hours or less following initiation of inhalation and at a time point 12 hours or more following initiation of inhalation. 
     
     
         11 . The method of  claim 1 , wherein the patient is headache free at a time point 15 minutes or less following initiation of inhalation. 
     
     
         12 . The method of  claim 1 , wherein the patient is headache free at a time point 2 hours or less following initiation of inhalation and at a time point 12 hours or more following inhalation. 
     
     
         13 . The method of  claim 1 , wherein the mass median aerodynamic diameter of the inhaled composition is about 1 micron to 3 microns. 
     
     
         14 . The method of  claim 1 , wherein the antipsychotic is a non-phenothiazine antipsychotic. 
     
     
         15 . The method of  claim 1 , wherein the non-phenothiazine antipsychotic is selected from haloperidol, droperidol, chlorprothixene, thiothixene, loxapine, molindone, pimozide, flupenthixol, zuclopenthixol, and melperone. 
     
     
         16 . The method of  claim 1 , wherein the patient self-administers one or more doses of the antipsychotic. 
     
     
         17 . The method of  claim 16 , wherein the patient self-administers a first dose of the antipsychotic, assesses relief after a given interval of time, and, if sufficient headache relief is not obtained, self-administers one or more additional doses. 
     
     
         18 . The method of  claim 17 , wherein the first dose is about 1 mg to 18 mg of the antipsychotic, and wherein the one or more additional doses is about 1 mg to 18 mg of the antipsychotic. 
     
     
         19 . A method of treating a migraine headache, comprising administering less than 9 mg of an antipsychotic to a patient in need of headache relief, wherein the peak plasma concentration of the antipsychotic is obtained within 15 minutes of initiation of administration of the antipsychotic, wherein a decrease in headache severity is obtained within 1 hour of initiation of administration of the antipsychotic, and wherein the decrease in headache severity persists for at least 12 hours after initiation of administration of the antipsychotic. 
     
     
         20 . The method of claim  29 , wherein the administration is via inhalation.

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